Pain Management, Total Hip Arthroplasty
Conditions
Keywords
Total Hip Arthroplasty, Postoperative Analgesia, Quadro-Iliac Plane Block
Brief summary
This prospective, randomized, double-blind study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane (QIP) block in patients undergoing primary total hip arthroplasty. The QIP block is a recently described fascial plane block. Patients will be randomized to receive either a QIP block with local anesthetic or a sham block with saline. The primary outcome is 24-hour opioid consumption. Secondary outcomes include motor block, dermatomal sensory assessment, pain scores, rescue analgesic requirement, quality of recovery (QoR-15), and opioid-related side effects.
Detailed description
Total hip arthroplasty is associated with significant postoperative pain. The Quadro-Iliac Plane (QIP) block is a recently described fascial plane block targeting the area where the quadratus lumborum muscle attaches to the iliac crest and may provide more comprehensive analgesia. This study is designed as a prospective, randomized, double-blind clinical trial including patients aged 18-80 years with ASA physical status I-III undergoing elective primary total hip arthroplasty. Patients will be randomized into two groups. The QIP group will receive an ultrasound-guided QIP block with 40 mL of 0.25% local anesthetic solution containing epinephrine, and the control group will receive a sham block with 40 mL of 0.9% NaCl using the same technique. The primary outcome is postoperative 24-hour opioid consumption. Secondary outcomes include motor block, and dermatomal sensory assessment, pain scores, quality of recovery (QoR-15), rescue analgesic requirement and opioid-related side effects
Interventions
PROCEDUREQuadro-Iliac Plane (QIP) Block
An ultrasound-guided Quadro-Iliac Plane block performed in the preoperative period. At the level of the iliac crest, 40 mL of a solution containing 0.25% levobupivacaine and 5 µg/mL epinephrine is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
PROCEDURESham Block
A sham block performed using the same ultrasound-guided technique in the preoperative period. At the level of the iliac crest, 40 mL of 0.9% NaCl is injected into the fascial plane between the erector spinae muscle and the quadratus lumborum muscle under aseptic conditions.
Sponsors
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study solutions will be prepared by an anesthesiologist who is not involved in patient care or data collection. The anesthesiologist performing the block and the patient will be blinded to group allocation. Postoperative assessments will be performed by an independent anesthesiologist who is also blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) classification I-III * Age between 18 and 80 years * Patients scheduled for elective primary total hip arthroplasty
Exclusion criteria
* Refusal to participate in the study * Allergy to local anesthetics or opioids * Known or suspected coagulopathy * Infection at the injection site * History of previous hip surgery * Severe cardiovascular disease * Liver or kidney failure * Pregnancy, suspected pregnancy, or breastfeeding * Severe neurological or psychiatric disorder * Chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative 24-Hour Morphine PCA Consumption | Postoperative 24 hours | Total amount of morphine delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Scores at Rest and Movement | 2, 6, 12, 24, and 48 hours postoperatively | Postoperative pain will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| QoR-15 Recovery Score | QoR-15 Recovery Score will be evaluated at the postoperative 48th hour | The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionnaire. PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed \[Total score range: 0-150 points\] |
| Lower Extremity Muscle Strength Score | Postoperative 6th and 12th hours | Postoperative lower extremity muscle strength will be assessed at the 6th postoperative hour using a 0-5 grading scale, where 0 indicates no muscle contraction and 5 indicates normal strength. The scale is defined as follows: 0 = no muscle contraction 1. = muscle contraction present without joint movement 2. = movement without overcoming gravity 3. = movement against gravity without resistance 4. = movement against partial resistance 5. = movement against full resistance (normal strength) |
| Rescue Analgesic Requirement | Postoperative 0-48 hours | Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4. |
| Opioid-Related Side Effects | Postoperative 0-48 hours | Opioid-related side effects will be assessed postoperatively Other opioid-related side effects, including pruritus, constipation, and somnolence, will be recorded as present or absent. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMursel Ekinci, Assoc prof,MD
CONTACTMustafa Dikici, MD
Outcome results
None listed